Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in elective Abdominal surgery: randomized controlled trial (TATRA)

Phase 1

Recruiting

Conditions: bleeding and transfusion requirements for major abdominal surgery, i.e., esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, and hepatectomy
MedDRA version: 20.1Level: LLTClassification code: 10051536Term: Intraoperative bleeding Class: 10022117
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Registration Number: CTIS2023-509970-43-01

Lead Sponsor: Martin-Luther-Universitaet Halle-Wittenberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 850

Inclusion Criteria

Patients =18 years, Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy, Adequate renal function with serum creatinine <250 µmol/L (2.82 mg/dL), Written informed consent obtained before randomization, Negative pregnancy test for women of childbearing potential within 14 days of com-mencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of <1% per year; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).

Exclusion Criteria

Severe anaemia (haemoglobin concentration <8 g/dL (<5 mmol/L)) or Anaemia with haemoglobin concentration =8 to <10 g/dL (=5,0 100 beats/minute, palpi-tation etc. • Clinical signs of hypotension, e.g., resting systolic blood pressure <100 mmHg, orthostatic dysregulation etc. • Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate >20 breaths/min., Thrombocytopenia with platelets <60 x 109 /L, Confirmed bleeding disorder with the need for specific preventive perioperative treat-ment (e.g., factor deficiency with the need of perioperative substitution), A priori refusal of blood transfusions, Confirmed thrombophilia with a pertinent need for perioperative anticoagulation, Allergy / hypersensitivity to TXA, Recent (<30 days) thromboembolic event, History of medically confirmed convulsions, In female subjects: pregnancy or lactation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial is to assess whether intraoperative administration of Tranexamic Acid reduces hemorrhage and thus the need for intra- and postoperative transfusion of packed red blood cells for major abdominal operations.;Secondary Objective: Secondary objectives are to evaluate the amount of intraoperative blood loss, the safety of administering tranexamic acid, the occurrence of complications after the operation, the length of inpatient hospital stay, and quality of life.;Primary end point(s): Intra- or postoperative transfusion of at least one unit of Packed Red Blood Cells (PRBCs)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):-Number of transfused Packed Red Blood Cells per patient -Estimated amount of intraoperative blood loss -Time to transfusion -Number and severity of postoperative in-hospital complications/mortality (max. 30 days) -Duration of hospital stay -Operation / Anaesthesia duration -D-dimer levels -Quality of life